Professional Documents
Culture Documents
QUALITY MANUAL
Version 2013
Name of the laboratory
Address
Director name
Contact details
Written by
Reviewed by
Authorized by
Date:
Date:
Date:
Quality
Manual
Preface
This quality manual template provides guidance for public health and clinical
laboratories on writing policies and procedures that support a quality
management system. It is based on both ISO 15189 Standard for Medical
laboratories - Medical laboratories Particular requirements for quality and
competence - and CLSI GP26-A4 documents - Quality Management System: A
Model for Laboratory Services; Approved guideline 4th edition - , and provides
information and examples to assist with writing a quality manual that addresses
all quality system essentials (QSE) that are critical for quality management. The
template is organized following the framework developed by CLSI and the 12
Quality System Essentials, as described in greater detail in the Laboratory
Quality Management System (LQMS) Training Toolkit 1. Furthermore, additional
resources (e.g. glossary) can also be found in the LQMS Training Toolkit and
Handbook.
A quality manual is required for implementing a quality management system.
Such a system aims primarily at achieving customer satisfaction by meeting
customer requirements through application of the system, continuous
improvement of the system, and prevention of the occurrence of
nonconformities.
This quality manual template is based on internationally-accepted standards and
focuses on good quality principles and best practices.
http://www.who.int/ihr/training/laboratory_quality/en/
Quality
Manual
BSL
Biosafety Level
CDC
CLSI
EQA
ISO
LIS
LQMS
QC
Quality Control
QM
Quality Manual
QMS
QSE
SOP(s)
WHO
Quality
Manual
2. Quality Policy...........................................................................................7
3. QSE: Organization....................................................................................8
3.1
3.2
3.3
3.4
3.5
3.6
Organization policy.................................................................................................................. 8
Conflict of interest................................................................................................................... 8
Organization chart................................................................................................................... 8
Internal communication........................................................................................................... 8
Personnel responsibilities........................................................................................................ 9
Supporting documents.......................................................................................................... 10
Policy..................................................................................................................................... 11
Facilities................................................................................................................................ 11
Security................................................................................................................................. 11
Working environment............................................................................................................ 11
Waste disposal...................................................................................................................... 11
Supporting documents.......................................................................................................... 12
5. QSE: Equipment.....................................................................................13
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
Policy..................................................................................................................................... 13
Selection of equipment.......................................................................................................... 13
Installation and Acceptance Criteria...................................................................................... 13
Equipment Inventory and master file..................................................................................... 13
Validation.............................................................................................................................. 13
Preventive maintenance and repair....................................................................................... 14
Decommissioning.................................................................................................................. 14
Supporting documents.......................................................................................................... 14
Quality
Manual
8. QSE: Assessments.................................................................................23
8.1 Policy..................................................................................................................................... 23
8.2 Internal assessments............................................................................................................. 23
8.2.1 Internal Audits................................................................................................................ 23
8.2.2 Review and follow up of corrective actions..................................................................... 23
8.2.3 Quality indicators........................................................................................................... 23
8.2.4 Staff suggestions............................................................................................................ 23
8.2.5 Review of requests, methods and sampling requirements..............................................24
8.3 External assessments............................................................................................................ 24
8.3.1 External Quality Assessment/ Proficiency testing...........................................................24
8.3.2 Customer feedback........................................................................................................ 24
8.3.3 External audits............................................................................................................... 24
8.4 Supporting documents.......................................................................................................... 24
9. QSE: Personnel.......................................................................................25
9.1 Policy..................................................................................................................................... 25
9.2 Recruitment........................................................................................................................... 25
9.3 Personnel file / health file...................................................................................................... 25
9.4 Integration and clearance...................................................................................................... 25
9.5 Training................................................................................................................................. 25
9.6 Staff competency.................................................................................................................. 26
9.7 Personnel performance appraisal.......................................................................................... 26
9.8 Continuous education............................................................................................................ 26
9.9 Non-permanent personnel..................................................................................................... 26
9.10 Supporting documents........................................................................................................ 26
Policy................................................................................................................................... 27
Customers satisfaction measurement.................................................................................. 27
Claims management........................................................................................................... 27
Supporting documents........................................................................................................ 27
Policy................................................................................................................................... 29
Quality indicators................................................................................................................ 29
Management review............................................................................................................ 29
Preventive action................................................................................................................. 30
Supporting documents........................................................................................................ 30
Policy................................................................................................................................... 31
Documentation management.............................................................................................. 31
Documents and records control........................................................................................... 31
Archiving............................................................................................................................. 32
Review of contracts............................................................................................................. 32
Supporting documents........................................................................................................ 32
Policy................................................................................................................................... 33
Information system - Security.............................................................................................. 33
Confidentiality..................................................................................................................... 33
Supporting documents........................................................................................................ 33
15. Appendices..........................................................................................34
Quality
Manual
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As part of the diagnostic services of XXX (if big structure), the Name of the
laboratory provides biochemistry, immunology, microbiology, parasitology,
toxicology, virology, haematology testing and other tests relevant to medicine
and/or disease surveillance to physicians, health care providers, and
epidemiologists for the benefit of the patient and population.
The laboratory has adopted a quality management system for the purpose of
the effective and efficient use of its resources. All employees are committed to
the culture of quality. All staff shares responsibility for identifying
nonconformities or opportunities for improvement, recording these instances
so that corrective or preventive actions can be taken to ensure the laboratory
meets the needs of its customers.
1.2 Mission statement
The objectives of the laboratory are to produce accurate, reliable and timely
analyses' results, achieve and maintain an effective quality management
system and ensure compliance with relevant statutory and safety
requirements.
These are usually defined by the laboratory director or senior administrative
management with staff participation.
The quality committee, through the quality manager, contributes to the
implementation of the quality management system to achieve the defined
objectives.
1.5 Scope
This quality manual describes the quality management system of the Name of
the laboratory. Its scope is for:
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2. Quality Policy
Senior management is dedicated to providing the resources necessary to
maintain the laboratory quality management system and to ensure the
laboratorys participation in the institutional quality plan.
The laboratory is committed to continual improvement, meeting internal
requirements and customer requirements, and providing a basis for the
establishment and review of the quality objectives.
Quality practices are communicated within the organization, understood and
adhered to by all employees.
The laboratory ensures a competent workforce to deliver quality results in a
timely manner according to the chosen internationally or nationally recognized
standard.
Quality
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3. QSE: Organization
3.1 Organization policy
The Name of the laboratory is not engaged in any activity that might influence its
technical judgment. The laboratory is not committed to any commercial,
financial or other pressure provided by any particular organization that could
influence its technical judgment or affect its competencies and trust.
3.3 Organization chart
Secretary:
Name
Quality manager:
Name
Quality team: Names
Immunology
department
Microbiology
department
Head name
Head name
Biochemistr
y
department
Parasitology
department
Head name
Head name
Technician(s
)
Technician(s
)
Technician(s
)
Technician(s
)
Name(s)
Name(s)
Name(s)
Name(s)
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Weekly meetings are held for all personnel in the laboratory. During the
meetings:
List the positions and their responsibilities. The exact titles of the positions (e.g.
director versus manager; manager versus officer) may vary between
organisations. The title in use should be selected as appropriate to the
environment by the management.
Laboratory director/manager (to be adapted)
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The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Communication
Conflict of interest
Review of the general organization
Procedures
Meetings management
Ap 1
Internal communication
Ethics and conflict of interest
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Organization review
Forms/Logs
Meeting minutes
Conflict of interest and ethics form
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The laboratory has several rooms, each designated for specific uses; for example,
offices, storage facilities, washrooms, patient collection area, and laboratory
working areas.
Include a labelled floor plan of the laboratory.
4.3 Security
The laboratory reception is clearly marked with the appropriate signage. Access
to all facilities other than reception is restricted to authorized personnel. Access
is regulated by an access card (magnetic badge or code).
Access to the BSL3 (Biosafety Level 3) requires:
a general training on biosafety concerning BSL3 level work
a tutorial by the person in charge of the BSL3
a specific clearance
a medical examination report communicating necessary vaccination.
Access to the laboratory outside the opening hours is limited to laboratory
management, technical staff and to personnel on duty call.
A 24-hour security service is in effect.
The facilities and zones at risk are linked to an alarm system at the central post
of security.
4.4 Working environment
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The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Facility maintenance
Security
Safe working environment
Waste disposal
Procedures
Safety manual (all specific safety procedures including biosafety)
Facility maintenance
Safe manipulation
Ap 2
Security
Waste disposal
Forms/Logs
Incident report form
Visitors log
Housekeeping log
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5. QSE: Equipment
5.1 Policy
New instruments and equipment are installed, calibrated and documented by the
vendor who assures satisfactory performance.
The vendor or laboratory ensures space, ventilation, humidity and electricity
meet specifications for satisfactory performance.
The vendor or laboratory provides documentation that each instrument meets all
the required criteria for its use in the laboratory.
5.4 Equipment Inventory and master file
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5.5 Validation
calibrated
to
ensure
it
meets
the
5.7 Decommissioning
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Ap 3
Equipment repair
Ap 4
Decommissioning
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Equipment identification
Procedures
Equipment selection (see chapter 6 Purchasing and Inventory)
Equipment validation
Equipment identification
Decontamination of laboratory equipment
Ap 5
Equipment decommission
Ap 6
Ap 6
Ap 5
Service certification
Ap 5
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The laboratory ensures that the procedures for the purchase, receipt and storage
of all reagents guarantee that the quality of testing is not compromised.
All new lots of reagents are crosschecked and documented with previous lots to
ensure reproducibility. Environmental conditions for the storage of all reagents
and consumables are monitored and documented.
The laboratory maintains a record of all laboratory supplies, including reagents
and consumables. This information includes:
identity of the reagent or consumable;
manufacturers name;
contact information for the supplier or the manufacturer;
date of receiving and date of entering into service;
condition when received (e.g. acceptable or damaged);
manufacturers instructions;
records that confirmed the reagent's or consumables initial acceptance for
use;
performance records that confirm the reagents or consumables ongoing
acceptance for use.
All reagents that are prepared within the laboratory, such as media, must contain
all the above information as well as the name of the person who prepared it and
the date of preparation.
6.3 Selection and evaluation of providers
The laboratory evaluates the providers for the reagents, consumables and
equipment. The evaluation should be conducted against defined criteria which
may include:
value for money
post-delivery support
availability
in-country distribution
registration of the provider.
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All the evaluations are recorded and a list of retained providers is established.
6.4 Procurement
6.4.1 Equipment procurement
The orders for purchase of supplies (reagents, consumables and materials) are
requested using a specific form and submitted to the provision/purchasing
department.
Receipt of orders
The laboratory confirms receipt of the supplies with the assistance of the
financial department/ provision department.
The date of receipt is recorded.
The person in the laboratory taking receipt of the supplies crosschecks the
information indicated on the package and accompanying documents with the
data of the order.
6.5 Stock management and inventory
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The laboratory ensures and can demonstrate that its subcontractor is competent
to perform the activities in question.
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Manual
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The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
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Manual
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The laboratory has processes for each phase of the sample processing: preexamination, examination and post-examination phases, to ensure accurate and
reliable testing.
The laboratory has quality control measures to monitor the examination phase of
testing (qualitative, quantitative and semi-quantitative).
Processes following the path of workflow:
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If the specimen needs to be shared for different tests throughout the laboratory
and/or storage purposes, each aliquot (sample) is labelled individually with the
unique registration number.
Samples are stored under proper temperature and safety conditions.
7.3 Method validation
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The laboratory has a Quality Control (QC) program with written policies and
procedures.
Laboratory technical staff is trained to review and take appropriate action
regarding quality control data.
Internal quality controls are required to ensure the results are valid.
The laboratory quality control program is a monitoring system that:
first, provides immediate information for making the decision about the
acceptability of patient results;
second, provides a method for evaluating data over time to help in making
decisions about the overall performance of the test procedure. These
controls are run on both qualitative (result is positive or negative) and
quantitative (result is a number or value) tests. The resulting data is
recorded in such a way that trends are detectable and, where practicable,
statistical techniques are applied to the reviewing of the results.
Equipment calibration and servicing are monitored.
The examinations results are documented by the technicians on the
corresponding records and recorded in a computer to create a permanent
traceable record.
If QC results are not validated, patients examination results cannot be reported.
When problems occur the laboratory investigates, corrects and repeats sample
testing (see chapter 11 Nonconforming Event Management).
7.7 Reporting
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
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Manual
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Ap 7
Sample labelling
Ap 8
Ap 9
Sample transport
Ap 10
Ap 11
Ap 12
Results reporting
Forms/Logs
Quality control logs
Test result form
List of examinations
Test request form
Ap 8
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8. QSE: Assessments
8.1 Policy
All corrective actions undertaken in the laboratory will be reviewed and their
follow up evaluated.
This is described in the chapter 11 Nonconforming Event Management.
8.2.3 Quality indicators
Quality indicators have been determined for XXX period of time to monitor the
quality objectives of the laboratory.
This monitoring is detailed in chapter 12 Continual Improvement.
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Manual
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All staff is encouraged to offer suggestions for improvement of any aspect of the
laboratory. These suggestions are recorded, evaluated and implemented if useful.
Feedback on the suggestions implemented is provided to the staff.
8.2.5 Review of requests, methods and sampling requirements
Proficiency testing serves as a tool for quality improvement in the laboratory. One
of the major benefits is identifying performance issues and correcting them.
List of the External Quality Assessment (EQA) programmes in which the
laboratory participates in:
List here the EQA programmes in which the laboratory participates in, with the
corresponding tests
8.3.2 Customer feedback
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Ap 13
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Manual
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9. QSE: Personnel
9.1 Policy
The laboratory recognizes that its most important resource is its personnel.
The laboratory management defines staff educational requirements and
competency qualifications necessary for conducting laboratory procedures.
The laboratory management strives to ensure recruitment is unbiased.
The laboratory works with the Human Resources department to ensure education
qualifications and references of job applicants are checked and to ensure legal
contracts/agreements are signed by all parties prior to employment or within a
set period.
The laboratory has a documented procedure for personnel management.
All personnel (temporary, permanent, students, etc.) sign a confidentiality
agreement.
All laboratory personnel respect the laboratory rules concerning health, safety
and security.
The laboratory provides training to its staff according to its needs.
9.2 Recruitment
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9.5 Training
The laboratory provides training for all personnel, which includes the quality
management system, assigned work processes and procedures, the laboratory
information system, health and safety, ethics and confidentiality.
The effectiveness of the training program is periodically reviewed.
9.6 Staff competency
Staff competencies cover technical and practical skills and general knowledge.
Competency of each new employee is assessed and verified before permitting to
perform testing and report results.
All employees are assessed for competency on an annual basis.
9.7 Personnel performance appraisal
Each staff is given the opportunity for an annual interview with the laboratory
director/manager.
9.8 Continuous education
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Ap 15
Competency assessment
Ap 16
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Manual
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Orientation checklist
Ap 14
Ap 16
Ap 16
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The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Customer satisfaction
See chapters 11 Nonconforming Event Management, and 12 Continual
Improvement
Procedures
Customer survey
Ap 17
Customer complaint
Ap 18
Forms/Logs
Customer survey form/questionnaire
Customer complaint logbook
Incident report
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Manual
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The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Ap 19
Corrective actions
Forms/Logs
Incident report
Corrective actions
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Manual
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The annual management review ensures that the organization and the activities
of the laboratory remain appropriate and efficient. Therefore, it allows the
evaluation and continuous improvement of the efficiency of the quality system of
the laboratory.
The elements reviewed are related to the quality system management.
Elements of entry of the management review:
quality objectives of the past year
quality indicators
occurrences and nonconforming events recorded
customer complaints reports
customer satisfaction survey reports
internal audit reports
proficiency testing reports
corrective/preventive actions and follow up
changes in work load or type of work
all pertinent factors: resources, future activities, etc.
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The laboratory reviews the data and implements preventive actions allowing the
laboratory to anticipate eventual nonconforming events in its activities. A follow
up of the actions implemented for improvement is ensured in the same way as
described in chapter 11 Nonconforming Event Management.
12.5 Supporting documents
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Continual review
Quality indicators
Management review
See chapters 8 Assessments, and 11 Nonconforming Event Management
Procedures
Quality indicators (including management and use)
Management review
Evaluation activities (see chapter 8 Assessments)
Forms/Logs
Review logs
Preventive actions
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Manual
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The laboratory ensures that documents and records are managed from creation
and receipt to archival and destruction, according to national laws, local
regulations and international standards.
13.2 Documentation management
The quality manager reviews and approves all requests for amendments to
existing documents and the development of new procedures, processes, and
policies.
Staff is not permitted to make temporary amendments to documentation without
the prior consent of the quality manager.
When new or modified policies, processes and procedures are instituted, staff
requires retraining.
The quality manual is reviewed periodically (establish time frame). All laboratory
procedures are reviewed on an annual basis. The responsibility for the annual
review lies with the document manager or quality manager.
The document manager or quality manager is responsible for the distribution of
new documents, retrieval of old documents and maintenance of records of
amendments.
13.3 Documents and records control
All documents are uniquely identified. Date of issue, revision version, total
number of pages and authorizing signatories are included in the document.
Documents are signed as a paper copy or authorized electronically.
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A document control log is maintained identifying the current valid versions and
their distribution.
A secure master file is maintained of all documents to prevent unauthorized
access, loss or damage.
13.4 Archiving
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Ap 20
Ap 21
Document management
Ap 22
Ap 23
Ap 24
Contract review
Forms/Logs
Document control logbook
Ap 24
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The Name of the laboratory has access to the data and information needed to
provide a service that meets the needs and requirements of internal and external
customers. The laboratory information system (LIS) (whether computerized or
paper-based) provides for the collection, processing, recording, storage, and
retrieval of data, and has documented procedures in place to ensure the
confidentiality of patient information and the security of the data during each
step of the process.
14.2 Information system - Security
The laboratory should develop its own complete list of supporting documents.
The table below suggests processes, procedures and forms/logs. Some but not all
documents are provided as examples in appendices and referred to as Ap XXX.
Processes
ID Code
Quality
Manual
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Forms/Logs
LIS down-time log
Back up log
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15. Appendices
Appendix 1: SOP: Meetings management
Appendix 2: SOP: Safe manipulation
Appendix 3: Process: Equipment installation
Appendix 4: Process: Equipment repair
Appendix 5: SOP: Decontamination of laboratory equipment; Forms: Checklist for
decontamination, Certification for service
Appendix 6: SOP: Equipment decommission; Form: Laboratory equipment
disposal
Appendix 7: SOP: General sampling conditions
Appendix 8: SOP: Sample labelling; Form: Test request
Appendix 9: SOP: Sample rejection or acceptance
Appendix 10: SOP: Sample transport
Appendix 11: SOP: Results validation
Appendix 12: SOP: Critical results reporting
Appendix 13: SOP: Internal audit
Appendix 14: Form: Orientation checklist
Appendix 15: SOP: Internal training
Appendix 16: SOP: Competency assessment; Forms: Competency assessment
checklist, Competency assessment logbook
Appendix 17: SOP: Customer survey
Appendix 18: SOP: Customer complaint
Appendix 19: SOP: Nonconforming event management
Appendix 20: Process: Internal documents management
Appendix 21: SOP: SOP management
Appendix 22: SOP: Document management
Appendix 23: SOP: Short term archiving
Appendix 24: SOP: Document control; Form: Document control logbook
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